DCB Angioplasty for Coronary Lesions: an OCT Analysis (NCT04984135) | Clinical Trial Compass
CompletedNot Applicable
DCB Angioplasty for Coronary Lesions: an OCT Analysis
China70 participantsStarted 2020-12-01
Plain-language summary
In this study, the investigators preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess the tissue characterization. The aim of this study was to investigate the relationship between quantitative and qualitative OCT findings, angiographic and clinical outcomes after PCB for coronary lesions.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Coronary angiography shows that at least one coronary artery has a diameter stenosis \>70% (left main stem diameter stenosis\>50%)
* Stable or unstable angina
* Availability for follow-up for up to 12 months
Exclusion Criteria:
* Acute myocardial infarction within 48 hours
* Severe calcified lesions
* Unable to tolerate dual antiplatelet treatment (DAPT)
* Severe abnormal hematopoietic system, such as platelet count of \< 100×109/L or \> 700×109/L and white blood cell count of \< 3×109/L
* Active bleeding or bleeding tendency
* Severe coexisting conditions, such as severe renal insufficiency (GFR \< 60 ml/min•1.73m2), severe hepatic dysfunction \[elevated ALT (glutamicpyruvic transaminase) or AST (glutamic-oxal acetic transaminase) level by more than three-fold of the normal limitation\], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc.
* Life expectancy \< 12 months
* Pregnancy or planning pregnancy
* Drug allergies or contraindications to aspirin, clopidogrel, ticagrelor, statins, contract, anticoagulant, stent, etc.
* Participation or planning to participate in another clinical trial during the same period
* Refusal to comply with the study protocol
What they're measuring
1
In-segment late lumen loss
Timeframe: 6 months
Trial details
NCT IDNCT04984135
SponsorThe First Affiliated Hospital of Dalian Medical University